(89 days)
No
The document describes a dental diode laser with various therapeutic and surgical applications. There is no mention of AI or ML in the device description, intended use, or performance studies. The testing focuses on electrical safety, laser safety, and biological evaluation, not algorithmic performance.
Yes
The device description explicitly states, "The SOLASE dental diode laser is a surgical and therapeutic device." Additionally, its indications for use include "Pain Relief," which describes therapeutic applications like temporary relief of minor muscle and joint pain, and increased local blood circulation.
No
The device description clearly states it is a "surgical and therapeutic device," and its intended uses are for procedures like incision, excision, vaporization, ablation, and pain relief, which are all therapeutic or surgical actions, not diagnostic ones.
No
The device description clearly states it is a "surgical and therapeutic device" that uses a "laser diode as the beam source" and delivers light via "optical fiber." This indicates a physical hardware component is central to its function, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical, therapeutic, and cosmetic procedures performed directly on the patient's oral tissues and teeth. These include incision, excision, vaporization, ablation, pain relief, and teeth whitening. None of these involve testing samples taken from the body in a laboratory setting.
- Device Description: The device is described as a "surgical and therapeutic device" that uses a laser to radiate light for direct application to the operating area. This aligns with a device used for treatment or procedures, not for diagnostic testing of samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue biopsies, etc.) to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on verifying design specifications and compliance with standards related to medical electrical equipment and laser safety, which are typical for surgical and therapeutic devices. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics relevant to IVDs.
In summary, the SOLASE dental diode laser is a medical device used for direct treatment and procedures on patients, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The indications for use of the subject device are given below.
- Dental soft tissue indications
Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
-
fibroma removal
-
frenectomy
-
frenotomy
-
gingival troughing for crown impressions
-
gingivectomy
-
gingivoplasty
-
hemostasis and coagulation
-
implant recovery
-
incision and drainage of abscess
-
operculectomy
-
pulpotomy
-
soft tissue crown lengthening
-
treatment of herpetic and aphthous ulcers of the oral mucosa.
-
- Laser periodontal procedures
-
laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
-
sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.)
-
- Whitening
-
light activation for bleaching materials for teeth whitening
-
laser-assisted whitening/bleach of teeth
-
- Pain Relief
-
topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle
Product codes
GEX
Device Description
The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue.
The SOLASE laser uses a laser diode as the beam source to radiate invisible infrared light, which is delivered to the operating area by optical fiber. It can generate a short laser pulse up to 10us of interval. The SOLASE laser provides two different models with two different wavelengths - 808nm and 976mm, to meet customers' various requirements.
The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, periodontal pocket
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
- IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
- ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- Performance data showing that the difference between the set average peak power and the measured average peak power meets performance criterion for the range of laser pulse specifications.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2018
Lazon Medical Laser Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn
Re: K180967
Trade/Device Name: Dental Diode Laser System, Models: Solace-808 and Solace-976 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: April 3, 2018 Received: April 13, 2018
Dear Diana Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180967
Device Name Dental Diode Laser System Models: SOLASE-808 and SOLASE-976
Indications for Use (Describe)
The indications for use of the subject device are given below.
- Dental soft tissue indications
Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
-
fiborma removal
-
frenectomy
-
frenotomy
-
gingival troughing for crown impressions
-
gingivectomy
-
gingivoplasty
-
hemostasis and coagulation
-
implant recovery
-
incision and drainage of abscess
-
operculectomy
-
pulpotomy
-
soft tissue crown lengthening
-
treatment of herpetic and aphthous ulcers of the oral mucosa.
-
- Laser periodontal procedures
-
laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
-
sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.)
-
- Whitening
-
light activation for bleaching materials for teeth whitening
-
laser-assisted whitening/bleach of teeth
-
- Pain Relief
-
topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K180967
-
- Date of Preparation: 7/10/2018
-
- Sponsor Identification
Lazon Medical Laser Co., Ltd. No.123, Hezuo Street, Dadong District, Shenyang, 110179, Liaoning, China.
Establishment Registration Number: Not yet registered
Contact Person: Gen Cheng Position: General Manager Tel: +86-24-88327588 Email: gen,cheng@lazonlaser.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
- Identification of Proposed Device 4.
Device Name: Dental Diode Laser System Model: SOLASE-808 and SOLASE-976 Common Name: Diode Laser
5
Regulatory Information
Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: General and Plastic Surgery
Indications for Use:
The indications for use of the subject device are given below.
-
- Dental soft tissue indications
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Dental soft tissue indications
-
fiborma removal
-
frenectomy
-
frenotomy
-
gingival troughing for crown impressions
-
gingivectomy
-
gingivoplasty
-
hemostasis and coagulation
-
implant recovery
-
incision and drainage of abscess
-
operculectomy
-
pulpotomy
-
soft tissue crown lengthening
-
treatment of herpetic and aphthous ulcers of the oral mucosa.
2. Laser periodontal procedures
-
laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
-
sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.)
3. Whitening
-
light activation for bleaching materials for teeth whitening
-
laser-assisted whitening/bleach of teeth
-
- Pain Relief
-
topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle
6
and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
Device Description
The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue.
The SOLASE laser uses a laser diode as the beam source to radiate invisible infrared light, which is delivered to the operating area by optical fiber. It can generate a short laser pulse up to 10us of interval. The SOLASE laser provides two different models with two different wavelengths - 808nm and 976mm, to meet customers' various requirements.
The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.
- ડ. Identification of Predicate Device and Reference Device
Predicate Device 510(k) Number: K121286 Product Name: Epic 10 Diode Laser System Model: Epic 10 Manufacturer: Biolase Technology, Inc.
Reference Device 510(k) Number: K103667 Product Name: Sapphire ST Portable Laser Manufacturer: Denmat Holdings LLC.
7
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- A IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
-
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
-
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin A sensitization
- A Performance data showing that the difference between the set average peak power and the measured average peak power meets performance criterion for the range of laser pulse specifications.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
8
8. Substantially Equivalent (SE) Comparison
Proposed Device | Predicate Device | Reference Device | |
---|---|---|---|
ITEM | K121286 | K103667 | |
Product Code | GEX | GEX | GEX |
Regulation | |||
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
Class | II | II | II |
Indications for | |||
Use | 1. Dental soft tissue | ||
indications | |||
Incision, excision, | |||
vaporization, ablation | |||
and coagulation of oral | |||
soft tissues including | |||
marginal and inter-dental | |||
gingival and epithelial | |||
lining of free gingiva | |||
and the following | |||
specific indications: |
- fibroma removal
- frenectomy
- frenotomy
- gingival troughing for
crown impressions - gingivectomy
- gingivoplasty
- hemostasis and
coagulation - implant recovery
- incision and drainage
of abscess - operculectomy
- pulpotomy-soft tissue
crown
lengthening-treatme
nt of herpetic and
aphthous ulcers of | 1. Dental Soft Tissue
Indications
Incision, excision,
vaporization, ablation and
coagulation of oral soft
tissues including marginal
and inter-dental gingival and
epithelial lining of free
gingiva and the following
specific indications:
- Excisional and incisional
biopsies - Exposure of unerupted
teeth - Fibroma removal
- Frenectomy
- Frenotomy
- Gingival troughing for
crown impressions - Gingivectomy
- Gingivoplasty
- Gingival incision and
excision - Hemostasis and coagulation
- Implant recovery
- Incision and drainage of | The Sapphire ST Portable
Diode Laser is intended for
use in dental intraoral soft
tissue general, oral
maxilla-facial and cosmetic
surgery. It is intended for
ablating, incising, excising,
vaporizing and coagulation of
soft tissues using a fiber optic
delivery system. Indications
include excision and incision
biopsies;, hemostatic
assistance; treatment of
aphthous ulcers; frenectomy;
frenotomy; gingival incision
and excision; gingivectomy;
gingivoplasty; incising and
draining abscesses;
operculectomy; oral
papillectomy; removal of
fibromias; Soft tissue crown
lengthening; sulcular
debridement (removal of
diseased or inflamed soft
tissue in the periodontal
pocket); tissue retraction |
| | | | |
| the oral mucosa. | abscess | for impression; | |
| | * Leukoplakia | vestibuloplasty, and light | |
| | * Operculectomy | activation of bleaching | |
| | * Oral papillectomnies | materials for teeth whitening, | |
| | * Pulpotomy | laser-assisted bleaching | |
| | * Pulpotomy as an adjunct to | /whitening of teeth. | |
| | root canal therapy | | |
| | * Reduction of gingival | | |
| | hypertrophy | | |
| | * Soft tissue crown | | |
| | lengthening | | |
| | * Treatment of canker sores, | | |
| | herpetic and aphthous ulcers | | |
| | of the oral mucosa. | | |
| | * Vestibuloplasty | | |
| | * Tissue retraction for | | |
| | impression | | |
| 2. Laser periodontal
procedures | 2. Laser Periodontal
Procedures | | |
| - laser removal of
diseased, infected,
inflamed and necrosed
soft tissue within the
periodontal pocket
- sulcular debridement
(removal of diseased,
infected, inflamed and
necrosed soft tissue in
the periodontal pocket to
improve clinical indices
including gingival index,
gingival bleeding index,
probe depth, attachment
loss and tooth mobility.) | * Laser soft tissue curettage
- Laser removal of diseased,
infected, inflamed and
necrosed soft tissue within
the periodontal pocket - Sulcular debridement
(removal of diseased,
infected, inflamed and
necrosed soft tissue in the
periodontal pocket to
improve clinical indices
including gingival index,
gingival bleeding index,
probe depth, attachment loss
and tooth mobility.) | | |
| | 3. Whitening
Light activation for
bleaching materials for
teeth whitening
*
Laser-assisted
whitening/bleaching
of
teeth
4. Pain Relief
- Topical heating for the
purpose of elevating
tissue temperature for a
temporary
relief
of
minor muscle and joint
pain and stiffness, minor
arthritis pain, or muscle
spasm, minor sprains
and strains, and minor
muscular back pain; the
temporary increase in
local blood circulation;
the temporary relaxation
of muscle. | 3. Whitening
- Light activation for
bleaching materials for teeth
whitening - Laser-assisted
whitening/bleaching of teeth
- Pain Relief
- Topical heating for the
purpose of elevating tissue
temperature for a temporary
relief of minor muscle and
joint pain and stiffness, minor
arthritis pain, or muscle
spasm, minor sprains and
strains, and minor muscular
back pain; the temporary
increase in local blood
circulation; the temporary
relaxation of muscle. | |
| Model | SOLASE-808 and
SOLASE-976 | Epic 10 | / |
| Laser
Classification | N(4) | N(4) | N(4) |
| Dimensions | 13.8cm×14.2cm×16.8cm | 14.5cm×11.2cm×16.5cm | Unknown |
| Weight | 1.3kg | 1.1kg | 1.2kg |
| Power Supply | 100-240VAC | 100-230VAC | 100-240 VAC |
| Current
Frequency | 50-60Hz | 50-60Hz | 50-60Hz |
| Laser Medium | AlGaAs | InGaAsP | Unknown |
| Wavelength | SOLASE-808: 808nm
SOLASE-976: 976nm | 940±10nm | 808±5nm |
| Max Output | CW mode: | 10W | CW: 3W |
| | | | |
| | 7W@SOLASE-808,
10W@SOLASE-976
Pulse mode:
12W@SOLASE-808,
16W@SOLASE-976 | | Pulse mode: 5W |
| Max Peak Pulse
Power | SOLASE-808: 12W
SOLASE-976: 16W | 10W | 5W |
| Max Average
Pulse Power | SOLASE-808: 6.3W
(When peak power is
0.17W) and 6W (When12W);
peak power is
7.1
SOLASE-976: 9W
(When peak power is
0.110W) and 8W16W) | Unknown | 2.5W |
(When peak power is
10.1
| Max Power
Density | SOLASE-808:
222.8W/mm²
SOLASE-976:
318.3W/mm² | 318.3W/mm² | 23.9 W/mm² |
| Power Modes | Continuous and Pulse | Continuous and Pulse | Continuous and Pulse |
| Pulse Length | 2.7m | Unknown | Unknown |
| Pulse Duration | 0.01ms-0.9s | 0.01ms-20ms | 0.1s |
| Pulse Interval | 0.01ms-0.9s | 0.01ms-20ms | 0.1s |
| Aiming Beam | 2mW, 650nm | 1mW, 635±10nm | 2mW, 640nm |
| Fiber Diameter | 200µm, 300µm and
400µm | 200µm, 300µm and 400µm | 400µm |
| Electrical Safety | Comply with IEC
60601-1 | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC
60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Particular
requirements | Comply with IEC
60601-2-22 and IEC
60825-1 | Comply with IEC
60601-2-22 and IEC 60825-1 | Comply with IEC
60601-2-22 and IEC 60825-1 |
| Patient-contact
material | Stainless steel,
aluminum, quartz and PP
(Polypropylene) | Medical grade plastics, steel,
stainless steel, aluminum,
brass, and electronic parts
and components | Unknown |
| Biocompatibility | Cytotoxicity, ISO
10993-5 | Unknown | Unknown |
| | Sensitization, ISO
10993-10 | | |
| | Irritation, ISO 10993-10 | | |
Table 1 Substantially Equivalent Comparison
9
10
11
12
The indications of proposed device is contained by those of predicate device, and proposed device and predicate device are similar in specifications. Although some of specifications of predicate device are not known and the materials are different, both the proposed device and predicate device comply the same standards in electrical safety, EMC and particular requirements, and the proposed device is demonstrated as non-toxic, non-irritating, and non-sensitizing per ISO 10993 series standards. The differences between the proposed device and predicate device do not impact the safety and effectiveness.
13
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.